OSI Pharmaceuticals Announces That “RADIANT”, an International Phase III Tarceva Adjuvant Trial in Non-Small Cell Lung Ca...
26 April 2010 - 10:00PM
Business Wire
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that it
has completed enrollment in the RADIANT study, a Phase III clinical
trial testing Tarceva® (erlotinib) as an adjuvant therapy in
patients with Stage IB-IIIA non-small cell lung cancer (NSCLC) who
have undergone surgery and have EGFR-positive tumors. RADIANT is an
international, randomized, double-blinded, placebo-controlled Phase
III study that has reached its enrollment goal of 945 patients. The
primary objective of the study is to determine whether the targeted
therapy Tarceva prolongs disease-free survival when given as an
adjuvant therapy. This is defined as a cancer treatment that is
given after the primary treatment, which is typically surgery or
surgery and chemotherapy in this group of NSCLC patients, to lower
the risk of the cancer coming back.
“We believe an oral therapy like Tarceva can be a valuable
addition to the treatment paradigm by extending the disease-free
survival of patients with Stage Ib-IIIa NSCLC,” said Colin Goddard,
Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “The study
has received considerable interest from both investigators and
patients and we look forward to the potential for interim results
in 2012 and final results in 2013-2014.”
About RADIANT
RADIANT is being conducted at approximately 240 sites in the
United States, Canada, Western and Eastern Europe, Asia Pacific and
Argentina. The study enrolled patients with surgically removed
Stage IB-IIIA NSCLC who have EGFR-positive tumors, as expressed by
immunohistochemistry (IHC) and/or fluorescence in-situ
hybridization (FISH), and who had completed up to four cycles of
standard adjuvant platinum-based chemotherapy or were chemotherapy
naive. Patients were randomized 2:1 to receive either Tarceva 150
mg or placebo once daily for two years.
The primary objective of RADIANT is to evaluate the
effectiveness of adjuvant therapy with Tarceva in prolonging
disease-free survival. Secondary objectives of the study include
comparing overall survival between study arms, evaluating the
safety of adjuvant Tarceva therapy, and exploring the predictive
value of EGFR-related biomarkers that may be associated with
clinical outcomes following treatment with Tarceva.
About Lung
Cancer
Lung cancer is the most common cancer worldwide with 1.5 million
new cases annually and NSCLC accounts for almost 85% of all lung
cancers. NSCLC progresses rapidly; less than 5% of advanced NSCLC
patients survive for five years.
About Tarceva
Tarceva is a once-a-day pill that targets the EGFR pathway.
Tarceva is designed to inhibit the tyrosine kinase activity of the
EGFR signaling pathway inside the cancer cell, one of the critical
growth factors in NSCLC and pancreatic cancer. The way Tarceva
works to treat cancer is not fully known.
Tarceva is prescribed for patients with
advanced-stage NSCLC whose cancer has not grown or spread
after initial treatment with certain types of chemotherapy. Tarceva
is also prescribed for people with advanced-stage NSCLC whose
cancer has not grown or spread after receiving at least one
chemotherapy regimen. Tarceva is not meant to be used at the same
time as certain types of chemotherapy for NSCLC. In pancreatic
cancer, Tarceva in combination with gemcitabine is prescribed
for patients with advanced-stage pancreatic cancer whose
cancer has spread, grown, or cannot be surgically removed,
and who have not received previous chemotherapy.
Tarceva Safety
There have been reports of serious Interstitial Lung Disease
(ILD)-like events including deaths in patients taking Tarceva.
Serious side effects (including deaths) in patients taking Tarceva
include liver and/or kidney problems; gastrointestinal (GI)
perforations (the development of a hole in the stomach, small
intestine, or large intestine); and severe blistering skin
reactions including cases similar to Stevens-Johnson syndrome.
Patients taking Tarceva plus gemcitabine were more likely to
experience bleeding and clotting problems such as heart attack or
stroke. Eye irritation and damage to the cornea have been reported
in patients taking Tarceva. Difficulty with blood clotting, and
bleeding events, including gastrointestinal and
non-gastrointestinal bleeding, have been reported in clinical
studies. Women should avoid becoming pregnant and avoid
breastfeeding while taking Tarceva. Patients should call their
doctor right away if they have these signs or symptoms: new or
worsening skin rash; serious or ongoing diarrhea, nausea, loss of
appetite, vomiting or stomach pain; new or worsening shortness of
breath or cough; fever; eye irritation. Rash and diarrhea were the
most common side effects associated with Tarceva in the NSCLC
clinical studies. Fatigue, rash, nausea, loss of appetite and
diarrhea were the most common side effects associated with Tarceva
plus gemcitabine therapy in the pancreatic cancer clinical
study.
For full prescribing information, please call 1-877-TARCEVA or
visit http://www.tarceva.com.
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality, novel and differentiated targeted medicines designed
to extend life and improve the quality of life for patients with
cancer and diabetes/obesity. For additional information about OSI,
please visit http://www.osip.com.
This news release contains forward-looking statements. These
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. Factors that might cause such
a difference include, among others, OSI's and its collaborators'
abilities to effectively market and sell Tarceva and to expand the
approved indications for Tarceva, OSI’s ability to protect its
intellectual property rights, safety concerns regarding Tarceva,
competition to Tarceva and OSI’s drug candidates from other
biotechnology and pharmaceutical companies, the completion of
clinical trials, the effects of FDA and other governmental
regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other
factors described in OSI Pharmaceuticals' filings with the
Securities and Exchange Commission.
Osi Pharmaceuticals (NASDAQ:OSIP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Osi Pharmaceuticals (NASDAQ:OSIP)
Historical Stock Chart
From Jul 2023 to Jul 2024